US12383543B2ActiveUtilityA1

Methods of treating prostate cancer

79
Assignee: JANSSEN PHARMACEUTICA NVPriority: Jul 29, 2016Filed: Nov 16, 2021Granted: Aug 12, 2025
Est. expiryJul 29, 2036(~10.1 yrs left)· nominal 20-yr term from priority
A61P 35/04A61P 13/08A61P 35/00A61K 9/0053A61K 31/454
79
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19
Claims

Abstract

Disclosed are methods of treating prostate cancer by administering niraparib to a human in need thereof.

Claims

exact text as granted — not AI-modified
We claim: 
     
       1. A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a therapeutically effective amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2. 
     
     
       2. The method of  claim 1 , wherein the prostate cancer is castration-resistant prostate cancer. 
     
     
       3. The method of  claim 1 , wherein the prostate cancer is metastatic castration-resistant prostate cancer. 
     
     
       4. The method of  claim 1 , wherein niraparib or a salt thereof is administered in an amount of from about 30 mg niraparib/day to about 400 mg niraparib/day. 
     
     
       5. The method of  claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 300 mg niraparib/day. 
     
     
       6. The method of  claim 5 , wherein niraparib or a salt thereof is administered orally, once daily, in 100 mg niraparib oral dosage forms. 
     
     
       7. The method of  claim 1 , wherein the human has had at least one line of taxane-based chemotherapy. 
     
     
       8. The method of  claim 1 , wherein the prostate cancer has been exposed to at least one line of enzalutamide-, apalutamide-, or abiraterone acetate-based chemotherapy. 
     
     
       9. A method of treating castration- and antiandrogen-resistant prostate cancer in a human comprising administering niraparib or a salt thereof in 100 mg niraparib oral dosage forms once daily to the human, wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2. 
     
     
       10. The method of  claim 9 , wherein niraparib or a salt thereof is administered in an amount of from about 30 mg niraparib/day to about 400 mg niraparib/day. 
     
     
       11. The method of  claim 9 , wherein niraparib or a salt thereof is administered in an amount of about 300 mg niraparib/day. 
     
     
       12. The method of  claim 9 , wherein the human has had at least one line of taxane-based chemotherapy. 
     
     
       13. The method of  claim 9 , wherein the prostate cancer has been exposed to at least one line of enzalutamide-, apalutamide-, or abiraterone acetate-based chemotherapy. 
     
     
       14. The method of  claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 200 mg niraparib/day. 
     
     
       15. The method of  claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 50 mg niraparib/day. 
     
     
       16. The method of  claim 1 , wherein the DNA repair anomaly is a genomic lesion. 
     
     
       17. The method of  claim 14 , wherein the genomic lesion is a homozygous deletion, heterozygous deletion plus deleterious mutation, or copy neutral loss of heterozygosity plus deleterious mutation. 
     
     
       18. The method of  claim 1 , further comprising determining whether the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2. 
     
     
       19. A method of treating prostate cancer in a human in need of such treatment comprising:
 determining whether the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2, and 
 administering to the human a therapeutically effective amount of niraparib or a salt thereof to a human who is carrying the at least one DNA repair anomaly, 
 wherein the prostate cancer is antiandrogen resistant.

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